NCT03588377

Brief Summary

The study assesses and compares the effect of 'pulse oximetry' (PO) used by Lady Health Workers (LHWs) at household level on increasing hospital referral acceptance rates in intervention clusters (district Jamshoro) for 0-59 months old children with severe pneumonia with the effect of LHWs using clinical signs alone in non-intervention clusters of the same district.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

May 12, 2018

Last Update Submit

March 29, 2022

Conditions

Severe PneumoniaHypoxemia

Outcome Measures

Primary Outcomes (2)

  • Hospital Referral Acceptance

    Number of children accepting hospital referral out of total severe pneumonia identified

    Day 3 to 7

  • Predictors of hospital referral acceptance

    number of children having the predictors (severe signs and symptoms, low distance from referral facility and high WAMI score)

    Day 0-3

Secondary Outcomes (1)

  • Comparison of clinical outcomes of children 0-59 months who accepted referral to those who refused admission and were treated at home

    Day 3 to Day 7

Study Arms (2)

Intervention Cluster

ACTIVE COMPARATOR

Signs and symptoms of severe pneumonia Pulse Oximetry

Device: Pulse Oximetry

Non-Intervention Cluster

NO INTERVENTION

Signs and symptoms of severe pneumonia

Interventions

Pulse OximetryDEVICE

Intervention clusters: On LHW's regular visits to households of their catchment area, they will daily screen for severe pneumonia and check oxygen level in blood using a pulse oximeter in all under \<5 children with symptoms of cough or difficulty breathing Case definition: 1. Birth - 6 days: Fast breathing +/- Low oxygen in blood \<92% (Hypoxemia) 2. 7 days - 59 months: Fast breathing and/or Chest In-drawing + Any one danger sign: (Low oxygen in blood \<92% (Hypoxemia), Refusing to eat, Vomiting continuously, Convulsions, Lethargy/ Unconsciousness, Stridor.

Intervention Cluster

Eligibility Criteria

Age0 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children of 0-59 months age
  • Signs of severe pneumonia (clinical signs only in control clusters, clinical signs and/or hypoxemia in intervention clusters)
  • Written informed consent by legal guardian

You may not qualify if:

  • \. Residents of out of catchment areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jāmshoro Office - AKU

Jāmshoro, Sindh, 76000, Pakistan

Location

Related Publications (1)

  • Mir F, Ali Nathwani A, Chanar S, Hussain A, Rizvi A, Ahmed I, Memon ZA, Habib A, Soofi S, Bhutta ZA. Impact of pulse oximetry on hospital referral acceptance in children under 5 with severe pneumonia in rural Pakistan (district Jamshoro): protocol for a cluster randomised trial. BMJ Open. 2021 Sep 17;11(9):e046158. doi: 10.1136/bmjopen-2020-046158.

    PMID: 34535473DERIVED

MeSH Terms

Conditions

PneumoniaHypoxia

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Gas AnalysisBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Officials

  • Fatima Mir, FCPS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 12, 2018

First Posted

July 17, 2018

Study Start

August 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

PA(1)